[Federal Register Volume 70, Number 132 (Tuesday, July 12, 2005)]
[Notices]
[Pages 40040-40042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


State Health Fraud Task Force Grants; Availability of Funds; 
Request for Applications; Correction; Funding Opportunity Number: FDA-
ORA-04-2; Catalog of Federal Domestic Assistance Number: 93.447

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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I. Funding Opportunity Description

    The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for State Health Fraud Task Force Grant 
Program support. This announcement supercedes previous announcements of 
this program, which were published in the Federal Register of June 28, 
2004 (69 FR 36091), and February 28, 2005 (70 FR 9656). Grant funds 
will be used to assist agencies in identifying and prosecuting 
perpetrators of health fraud and acquired immunodeficiency syndrome 
(AIDS) health fraud; obtain and disseminate information on the use of 
fraudulent drugs and therapies; disseminate information on approved 
drugs and therapies; and provide health fraud information obtained by 
the State Health Fraud Task Force to State health agencies, community 
based organizations, and FDA staff.
    FDA will support projects covered by this notice under sections 
1702 through 1706 of title XVII of the Public Health Service Act (42 
U.S.C. 300u-1 through 300u-5). FDA's project program is described in 
the Catalog of Federal Domestic Assistance, No. 93.447.
    The State Health Fraud Task Force has the following mission: (1) To 
assist and educate health professionals and persons with serious 
illnesses, and to educate them about the dangers and magnitude of 
health fraud; (2) to assist law enforcement agencies in identifying and 
prosecuting perpetrators of health fraud; (3) to obtain and disseminate 
information on the fraudulent drugs and therapies being used and the 
consequences of their use; (4) to disseminate information on approved 
drugs and therapies; and (5) to provide health fraud information 
obtained by the State Health Fraud Task Force to State health agencies, 
community based organizations, and FDA staff.
    State Health Fraud Task Force grants will be awarded only for 
direct costs incurred to accomplish the mission of the State Health 
Fraud Task Force Program in educating and combating health fraud.

II. Award Information

    Support of these grants will be for up to 3 years. The number of 
grants awarded will depend on the quality of the applications received 
and the availability of Federal funds to support the grant. These 
grants are not intended to fund food, medical devices, or drug 
inspections. Only one award will be made per State.
    State Health Fraud Task Force grants will be awarded for up to 3 
years based on availability of funds and satisfactory performance. The 
budgets for all years of requested support must be fully justified in 
the original application.
    Support for this program will be in the form of a grant.

1. Award Amount

    It is anticipated that each year approximately $300,000 will be 
available for this program. FDA anticipates making approximately 20 
awards, not to exceed $15,000, in direct costs only per award per year.

2. Length of Support

    It is anticipated that FDA will fund these grants at a level 
requested but not exceeding $15,000 total direct costs only for the 
first year. An additional 2 years of support up to approximately 
$15,000 total direct costs only each year will be available, depending 
upon the following factors: (1) Performance during the preceding year, 
(2) compliance with regulatory requirements of the award, and (3) 
availability of Federal funds.

3. Funding Plan

    The number of grants funded will depend on the quality of the 
applications received, their relevance to FDA's mission, priorities, 
and the availability of funds.

III. Eligibility Information

    Applicants are limited to States that have an existing AIDS Health 
Fraud Task Force or States that are in the process of developing a 
Health Fraud Task Force.

1. Eligible Applicants

    This grant program is only available to one State Health Fraud Task 
Force per State.

2. Cost Sharing or Matching

    None.

3. Other

    An application will be considered nonresponsive if any of the 
following circumstances are met: (1) If it is

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received after the specified receipt date; (2) if the total dollar 
amount requested from FDA exceeds $15,000 per year; (3) if all required 
original signatures are not on the face, assurance, or certification 
pages of the application; (4) if there is no original signature copy; 
(5) if it is illegible; (6) if the material presented is insufficient 
to permit an adequate review; or (7) if the application demonstrates an 
inadequate understanding of the intent of the Request For Application 
(RFA).
    A fiscal agent, who will be responsible for the administrative 
responsibilities for grant funds to conduct their activities, must be 
identified on the application. A program director, also known as the 
State Health Fraud Task Force Chair, must be identified as being 
responsible for submission of the application, and a complete listing 
of all State Health Fraud Task Force members and their credentials must 
be included in the application.
    Responsiveness is defined as submission of a complete application 
with original signatures on or before the required submission date as 
listed previously in this document. If an application is found to be 
nonresponsive, it will be returned to the applicant without further 
consideration.

IV. Application and Submission

1. Address to Request Application

    FDA is accepting new applications for this program electronically 
via Grants.gov. Applicants are strongly encouraged to apply 
electronically by visiting the Web site http://www.grants.gov and 
following instructions under ``APPLY.'' The applicant must register in 
the Central Contractor Registration (CCR) database in order to be able 
to submit the application electronically. Information about CCR is 
available at http://www.grants.gov/CCRRegister. The applicant must 
register with the Credential Provider for Grants.gov. Information about 
this requirement is available at http://www.grants.gov/CredentialProvider. (FDA has verified the Web site address, but FDA is 
not responsible for subsequent changes to the Web site after the 
document publishes in the Federal Register).
    If applicants experience technical difficulty with online 
submissions, applicants should contact either Djuana Gibson, Division 
of Contracts and Grants Management (HFA-500), Food and Drug 
Administration, 5600 Fishers Lane, rm. 2141, Rockville, MD 20857, 301-
827-7177, e-mail: [email protected], or the Grants.gov Contact Center 
at 1-800-518-4726. An application not received in time for orderly 
processing will be returned to the applicant without consideration.

2. Content and Form of Application

    Applicants are strongly encouraged to contact FDA to resolve any 
questions regarding criteria prior to the submission of their 
applications. All questions of a technical or programmatic nature must 
be directed to the Office of Regulatory Affairs (ORA) program staff 
(see section VII of this document) and all questions of an 
administrative or financial nature must be directed to the grants 
management staff (see section IV.1 of this document).
    No supplemental material or addenda will be accepted after the 
receipt date.
    A properly formatted sample application for grants can be accessed 
on the Internet at http://www.fda.gov/ora/fed_state/Innovative_Grants.html.
    The face page of the application should indicate ``Response to RFA-
FDA-ORA-04-2.''
    The Division of Federal-State Relations will provide meeting 
guidelines and organization documents as requested.

3. Submission Dates and Times

    The application receipt date for fiscal year 2005 is August 11, 
2005 for new applications. Each subsequent year that this program is in 
effect the receipt date will be April 30.
    Applications will be accepted from 8 a.m. to 4:30 p.m., Monday 
through Friday, until the established receipt date.

4. Intergovernment Review

    The regulations issued under Executive Order 12372, 
Intergovernmental Review of Department of Health and Human Services 
Programs and Activities (45 CFR part 100), apply to this program. 
Executive Order 12372 sets up a system for State and local government 
review of applications for Federal financial assistance. Applicants 
(other than federally recognized Indian tribal governments) should 
contact the State's Single Point of Contact (SPOC) as early as possible 
to alert the SPOC to the prospective application(s) and to receive any 
necessary instructions on the State's review process. A current listing 
of SPOCs is included in the application kit or at http://www.whitehouse.gov/omb/grants/spoc.html. (FDA has verified the Web site 
address, but FDA is not responsible for subsequent changes to the Web 
site after the document publishes in the Federal Register). The SPOC 
should send any State review process recommendations to FDA's 
administrative contact (see section IV.1 of this document). The due 
date for the State process recommendations is no later than 60 days 
after the deadline date for the receipt of applications. FDA does not 
guarantee to accommodate or explain SPOC comments that are received 
after the 60-day cutoff.

5. Funding Restrictions

    Examples of direct costs may include the following items: (1) 
Conferences/workshops sponsored by the task force, (2) development of 
public service announcements/campaigns, (3) health fraud brochures, and 
(4) travel expenses for face-to-face State Health Fraud Task Force 
meetings. Grant funds may be used to cover the cost of the program 
director, or task force chair, to attend one non-FDA sponsored health 
fraud related meeting and one FDA-sponsored National Health Fraud Task 
Force Steering Committee meeting per year. Grant funds may not be used 
to purchase meals in conjunction with any activities sponsored by the 
State Health Fraud Task Force or for any Federal employee to travel to 
any task force meeting or to participate in any task force activity. 
FDA region/district representatives may be invited to be liaisons or 
advisors of the State Health Fraud Task Force but each task force 
should develop its own guidelines for work, consensus decisionmaking, 
size, and format.

6. Other Submission Requirements

    Do not send applications to the Center for Scientific Research, 
National Institutes of Health (NIH). Any application sent to NIH that 
is then forwarded to FDA and not received in time for orderly 
processing will be deemed unresponsive and returned to the applicant. 
FDA is able to receive applications via the Internet.
    Since October 1, 2003, applicants are required to have a DUNS 
number to apply for a grant or cooperative agreement from the Federal 
Government. The DUNS number is a 9-digit identification number, which 
uniquely identifies business entities. Obtaining a DUNS number is easy 
and there is no charge. To obtain a DUNS number, call 1-866-705-5711. 
Be certain that you identify yourself as a Federal grant applicant when 
you contact Dun and Bradstreet.

V. Application Review Information

1. Criteria

    Applications will be given an overall score and judged based on all 
of the following criteria equally: (1) The

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content/subject matter and how current and appropriate it is for FDA's 
mission; (2) the educational outreach plan and how thorough, 
reasonable, and appropriate it is for accomplishing the mission of the 
program; (3) the experience, training, and competence of the program 
director and task force members as described in the application; (4) 
the reasonableness of the proposed budget given the plan for achieving 
the objective of the mission of the State Health Fraud Task Force 
Program; (5) a plan for self-sustaining the task force program in the 
event that Federal funding were to become unavailable in the future; 
(6) a brief history of the existing State Health Fraud Task Force and 
its accomplishments, not to exceed two typewritten pages; (7) a 
description of the structure of the existing State Health Fraud Task 
Force including such items as nonprofit organizational status, 
membership guidelines, or other relevant information to demonstrate the 
task force as a recognizable structured entity.

2. Review and Selection Process

    This program is primarily intended for previously established 
Health Fraud Task Forces. However, consideration will be given to newly 
formed task forces that meet the requirements of this RFA.
    All applications submitted in response to this RFA will first be 
reviewed by grants management and program staffs for responsiveness.
    Responsive applications will be reviewed and evaluated for 
scientific and technical merit by an ad hoc panel of experts in the 
subject field of the specific application. Applications will be 
considered for funding on the basis of their overall technical merit as 
determined through the review process. Other award criteria will 
include availability of funds and overall program balance. Funding 
decisions will be made by the Commissioner of Food and Drugs or his 
designee.

VI. Award Administration Information

1. Award Notice

    FDA's Grants Management Office will notify applicants who have been 
selected for an award. Awards will either be issued on a Notice of 
Grant Award (Public Health Service (PHS) 5152) signed by the FDA Chief 
Grants Management Officer and be sent to the applicant by mail or 
transmitted electronically.

2. Administrative and National Policy Requirements

    These grants will be subject to all policies and requirements that 
govern the project grant programs of PHS, including the provisions of 
42 CFR part 52, 45 CFR parts 74 and 92, and the PHS Grants Policy 
Statement.
    FDA urges applicants to submit work plans that address specific 
objectives of ``Healthy People 2010.'' Applicants may obtain a paper 
copy of the ``Healthy People 2010'' objectives, vols. I and II, for $70 
($87.50 foreign), S/N 017-000-00550-9, by writing to the Superintendent 
of Documents, U.S. Government Printing Office, P.O. Box 371954, 
Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-
2250. The document is also available in CD-ROM format, S/N 017-001-
00549-5, for $19 ($23.50 foreign), as well as on the Internet at http://www.health.gov/healthypeople/ under ``Publications.'' (FDA has 
verified the Web site address, but FDA is not responsible for 
subsequent changes to the Web site after the document publishes in the 
Federal Register).

3. Reporting

    Semiannual progress reports as well as a final program progress 
report are required. The grantee must submit a progress report and two 
copies to FDA's grants management officer in the middle of each budget 
period and also within 90 days after the end of each budget period. The 
final progress report, due 90 days after the end of the project period, 
must provide full written documentation of the project, copies of any 
results (as described in the grant application), and an analysis and 
evaluation of the results of the project.
    An annual financial status report (FSR) is due 90 days after the 
end of each budget period. The final FSR is due 90 days after the end 
of the project period.
    Program monitoring of recipients will be conducted on an ongoing 
basis and written reports will be reviewed and evaluated at least 
semiannually by the project officer. Project monitoring may also be in 
the form of telephone conversations between the project officer/grants 
management specialist and the principal investigator and/or a site 
visit with appropriate officials of the recipient organization. The 
results of these monitoring activities will be recorded in the official 
file and may be available to the recipient upon request consistent with 
applicable disclosure statutes and with FDA disclosure regulations.

VII. Agency Contacts

    Regarding the administrative and financial management aspects of 
this notice: Djuana Gibson (see section IV.1 of this document).
    Regarding the programmatic aspects of this notice: Stephen Toigo, 
Division of Federal-State Relations (HFC-150), Office of Regulatory 
Affairs, Food and Drug Administration, 5600 Fishers Lane, rm. 12-07, 
Rockville, MD 20857, 301-827-6906, or access the Internet at http://www.fda.gov/ora/fed_state/default.htm. For general ORA program 
information contact your Public Affairs Specialists at http://www.fda.gov/ora/fed_state/DFSR_Activities/.

VIII. Other Information

    Data included in the application, if restricted with the legend 
specified in this section of the document, may be entitled to 
confidential treatment as trade secret or confidential commercial 
information within the meaning of the Freedom of Information Act (FOIA) 
(5 U.S.C. 552(b)(4)) and FDA's implementing regulations (21 CFR 20.61).
    Information collection requirements requested on PHS Form 5161-1 
were approved and issued under Office of Management and Budget Circular 
A-102.
    Unless disclosure is required under FOIA as amended (5 U.S.C. 552), 
as determined by the freedom of information officials of the Department 
of Health and Human Services or by a court, data contained in the 
portions of an application that have been specifically identified by 
page number, paragraph, etc., by the applicant as containing restricted 
and/or proprietary information, shall not be used or disclosed except 
for evaluation purposes.

    Dated: July 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-13635 Filed 7-11-05; 8:45 am]
BILLING CODE 4160-01-S